Draft paper on national policy for the medical devices- reduce imports from 80% to 30% in next 10 years.

 

The department of pharmaceuticals (DoP) has released a draft paper on national policy for the medical devices, inviting feedback and remarks of the industry and stakeholders, till the 25 March. The efforts of the government is to reduce import dependence from 80% to below 30% in next 10 years and ensure self-reliance quotient of 80% in Med-Tech by ensuring Make in India with SMART milestones.The report envisaged that by 2047, 

1. India will be one amongst Top 5 Global manufacturing hubs in terms of value and technology for Medical Devices. 
2. India will be home to 25 MedTech $Bn companies and home & originator to 25 high end futuristic technologies in MedTech. 
3. India will emerge as Champion in critical components, cancer diagnostics, medical imaging, ultrasonic scans, molecular imaging, & PCR technologies .India will achieve 10-12% of Global Market Share of Medical Devices Sector to arrive at a $100-300 Bn industry.
4. India will have about 50 Medical Devices Clusters across India for faster clinical testing of Medical Devices to boost product development and innovation.

The Government has allowed 100% foreign direct investments (FDI) in medical devices sector while prescribing that domestically sourced components must contribute to 25-50 per cent of the cost of medical devices to qualify for public tenders and also has notified 135 in-vitro diagnostic medical devices and 19 medical devices where there is sufficient local capacity and local competition available in the country.

Recognizing the need for higher levels of investments for the creation of testing and laboratory facilities, the sub-scheme “Assistance to Medical Device Industry for Common Facility Centre” has been revised and renamed as “Promotion of Medical Device Parks” which has been approved by the Government of India on 20th March 2020. The parks will provide common testing and laboratory facilities/centre at one place reducing the manufacturing cost significantly and will help in creating a robust ecosystem for medical device manufacturing in the country. The total financial outlay of the scheme is ₹ 400 crore and the maximum assistance under the scheme for one Medical Device Park would be limited to ₹ 100 crore. The model is Andhra Pradesh MedTech Zone, India’s first exclusive medical device manufacturing park result of MoU signed between the state government and Association of Indian Medical Devices Industry (AiMeD), the Foundation Stone of the 270-acre exclusive manufacturing park was laid on August 19, 2016 at Nadupur village of Pedda Gantyada Mandal in Vishakhapatnam by Andhra Pradesh Chief Minister Mr Chandrababu Naidu.

Medical Devices Rules, 2017.

Some aspects relevant to innovators:
   1. Government will be appointing medical Device Testing Officers.

(1) The Central Government may designate a Government Analyst appointed under section 20 of the Act as Medical Device Testing Officer.

(2) The Central Government or, as the case may be, the State Government, may designate an Inspector appointed under section 21 of the Act as Medical Device Officer.  

2. Government to establish Medical Device Testing Laboratory.

(1) The Central Government may, by notification, establish Central medical devices testing laboratory for the purpose of,(a)testing and evaluation of medical devices; or (b)functioning as an appellate laboratory; or(c)to carry out any other function as may be specifically assigned to it.

(2) Without prejudice to sub-rule (1), the Central Government may also designate any laboratory having facility for carrying out test and evaluation of medical devices as central medical devices testing laboratory .

3. Application for registration of medical device testing laboratory:

(1) An application for grant of registration of a medical device testing laboratory to carry out

testing or evaluation of a medical device on behalf of a manufacturer shall be made to the Central Licensing Authority through online portal of the Central Government in Form MD-39 accompanied with a fee as specified in the Second Schedule along with the information specified in sub-rule (2).        

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